FDA 483 - Samson Pharmaceuticals, Inc - January 29, 2020

An FDA inspection of Samsan Pharmaceuticals, Inc. in Commerce, CA, revealed significant deficiencies across multiple systems, particularly concerning the manufacturing of Pure Eyes sterile eye drops. The firm failed to maintain adequate quality control, ensure aseptic processing integrity, and properly manage stability testing and component identification. These issues indicate a serious lack of adherence to good manufacturing practices for sterile drug products.